A bill

 

TO AMEND THE SOUTH CAROLINA CODE OF LAWS by ENACTing THE "PRESSLEY CAVIN STUTTS, JR., PATIENT AND HEALTH PROVIDER PROTECTION ACT"; AND BY ADDING SECTION 44-53-364 SO AS TO AUTHORIZE THE PRESCRIBING OF OFF-LABEL MEDICATIONS AND, IF PRESCRIBED, TO REQUIRE THEIR DISPENSING, WITH EXCEPTIONS.

 

Be it enacted by the General Assembly of the State of South Carolina:

 

SECTION 1.  This act may be cited as the "Pressley Cavin Stutts, Jr., Patient and Health Provider Protection Act".

 

SECTION 2.  Article 3, Chapter 53, Title 44 of the S.C. Code is amended by adding:

 

    Section 44-53-364. (A) As used in this section:

       (1) "Health-related licensing board" means a state board authorized pursuant to Title 40 to issue a license to engage in the practice of a licensed health professional authorized to prescribe drugs.

       (2) "Hospital" has the same meaning as in Section 44-7-130 and includes a hospital owned or operated by the United States Department of Veterans Affairs.

       (3) "Identified" means that a hospital or inpatient facility pharmacist has determined that a patient's off-label drug is in the original manufacturer's packaging or is labeled from an outpatient retail pharmacy, has been approved by the prescriber for use, and is not outside of its beyond-use date.

       (4) "Inpatient facility" means either or both of the following:

           (a) a nursing home as defined in Section 44-7-130; or

           (b) a freestanding inpatient rehabilitation facility licensed under Article 3, Chapter 7, Title 44.

       (5) "Off-label drug" means a drug that is both of the following:

           (a) approved by the United States Food and Drug Administration to treat or prevent a disease, illness, or infection, but prescribed for or used by a patient to treat or prevent another disease, illness, or infection; and

           (b) legal for use in this State.

       (6) "Pharmacist" means an individual who holds a license issued pursuant to Chapter 43, Title 40, authorizing the individual to practice pharmacy.

       (7) "Political subdivision" means a county, township, municipal corporation, school district, or other body corporate and politic responsible for governmental activities in a geographic area smaller than that of the State. "Political subdivision" also includes a board of health of a city or general health district.

       (8) "Prescriber" means a physician licensed pursuant to Chapter 47, Title 40; an advanced practice registered nurse licensed pursuant to Chapter 33, Title 40 and prescribing in accordance with the requirements of that chapter; or a physician assistant licensed pursuant to Article 7, Chapter 47, Title 40 and prescribing in accordance with the requirements of that article.

       (9) "Public official" means any officer, employee, or duly authorized agent or representative of a state agency or political subdivision.

       (10) "State agency" means any organized agency, board, body, commission, department, institution, office, or other entity established by the laws of the State for the exercise of any function of state government. "State agency" does not include a court.

    (B) A prescriber may issue for a patient a prescription for any drug, including an off-label drug, if the prescriber has obtained the patient's informed consent or the consent of the person holding the patient's health care power of attorney. All of the following apply to the prescribing of an off-label drug under this subsection:

       (1) The prescriber is not required to obtain a test result before issuing the prescription for the patient's use of the drug at home or for other outpatient treatment.

       (2) The patient is not required to have had a positive screen for a particular disease, illness, or infection before the prescriber issues the prescription.

       (3) The patient is not required to have been exposed to a disease, illness, or infection before the prescriber issues the prescription for the patient's prophylactic use of the drug.

    (C)(1) A pharmacist shall dispense, and a hospital or inpatient facility shall allow the dispensing of, an off-label drug to a patient if a prescriber has issued for the patient a prescription for the drug as described in subsection (B), except if either of the following is the case:

           (a) As provided in Chapter 139, Title 44, the pharmacist, hospital, or inpatient facility has a moral, ethical, or religious belief or conviction that conflicts with the drug's dispensing.

           (b) The pharmacist has documented that the patient has a history of a life-threatening allergic reaction to the prescribed off-label drug or there is a life-threatening contraindication.

       (2) When a pharmacist must dispense, or a hospital or inpatient facility must allow the dispensing of, an off-label drug for a patient pursuant to this section, but the pharmacist, hospital, or inpatient facility has an objective, good-faith, and scientific objection to the administration or dosage of the drug for that patient, the pharmacist, hospital, or inpatient facility shall be immune from administrative or civil liability for any harm that may arise from the dispensing or use of the off-label drug starting from the date of dispensing, so long as both of the following are done:

           (a) At the time of dispensing, the pharmacist, hospital, or inpatient facility documents in the patient's medical record the objective, good-faith, and scientific objection, by stating with particularity the basis of that objection, which must be based on an individualized assessment of the patient and the off-label drug.

           (b) The pharmacist submits to the Board of Pharmacy or the hospital or inpatient facility submits to the Department of Public Health, the objective, good-faith, and scientific objection by stating with particularity the basis of that objection, which must be based on an individualized assessment of the patient and the off-label drug.

       (3)(a) In the case of a pharmacist who practices within a hospital's or inpatient facility's pharmacy and where an in-house treating prescriber issues for a hospital or facility patient a prescription for an off-label drug that is neither in stock nor listed on the hospital's or facility's formulary, the pharmacist must document in the patient's medical record that a good-faith effort was made to find out if the drug is available from another hospital or inpatient facility or another distributor. If available, the drug must be offered to the patient at an upfront, out-of-pocket cost to the patient. The hospital or inpatient facility may require payment prior to ordering the drug.

           (b) If the hospital or inpatient facility pharmacist is unable to obtain the off-label drug from another hospital, inpatient facility, or distributor or if the hospital, hospital pharmacist, inpatient facility, or pharmacist declines to fill the prescription for the reasons provided in Chapter 139, Title 44, and the patient has access to the drug through a pharmacy outside the hospital or inpatient facility or has the drug available at home, then both of the following apply:

               (i) The hospital or inpatient facility must permit that drug to be brought into the hospital or inpatient facility to be identified for the patient's use and administration within the hospital or inpatient facility.

               (ii) When the hospital or inpatient facility or the patient's in-house treating prescriber or other in-house treating clinician is unwilling to administer the drug to the patient for reasons provided in Chapter 139, Title 44, then another prescriber or prescriber's delegate may administer the drug.

       (4) When a patient cannot be safely transported out of a hospital or inpatient facility and the patient or person holding the patient's health care power of attorney wishes to try an off-label drug to treat the patient's condition, but there is no in-house prescriber willing to prescribe the drug, then the patient's outpatient physician prescriber, after a prompt consultation with the patient's hospital or inpatient facility care team and a review of all of the patient's drugs, shall be allowed to immediately begin applying for temporary privileges with oversight, based on criteria within the hospital or inpatient facility medical staff bylaws. The temporary privileges approval process is not to exceed five days. If the outpatient physician prescriber does not meet the facility's medical staff bylaw requirements, then the denial shall be reported to the Department of Public Health. If the outpatient physician prescriber meets the facility's medical staff bylaw requirements, then the prescriber shall immediately be allowed to participate in the patient's care in the narrowed scope of practice regarding the administering and monitoring of the prescribed off-label drug within the hospital or inpatient facility until the patient is in a condition where the patient can be safely transported to a hospital or inpatient facility where the outpatient physician prescriber is credentialed. In such a case, all of the following apply:

           (a) The patient may be required to pay out-of-pocket for the prescribed off-label drug before it is ordered.

           (b) If the hospital or inpatient facility cannot obtain the off-label drug being prescribed by the outpatient physician prescriber, then the requirements of item (3)(b)(i) and (ii) apply.

           (c) The in-house pharmacist, hospital, or inpatient facility and the in-house physician responsible for the patient's care shall be immune from administrative and civil liability for any harm that may arise from the patient's use of the off-label drug prescribed by the outpatient physician prescriber starting from the date of dispensing.

       (5) All of the following apply to the dispensing of an off-label drug under item (1) or (2):

           (a) The pharmacist is not required to obtain a test result before dispensing the drug for the patient's use at home or for other outpatient treatment.

           (b) The patient is not required to have had a positive screen for a particular disease, illness, or infection before the pharmacist dispenses the drug.

           (c) The patient is not required to have been exposed to a disease, illness, or infection before the pharmacist dispenses the drug for prophylactic use.

       (6) Nothing in this section prevents a pharmacist from discussing a prescription with the prescriber who issued the prescription.

    (D)(1) A health-related licensing board, the Department of Public Health, the State Board of Pharmacy, or any other state board or agency responsible for the licensure or regulation of health care professionals shall not consider any action taken by a prescriber or pharmacist or hospital or inpatient facility under this section to be unlawful, unethical, unauthorized, or unprofessional conduct and shall not pursue an administrative or disciplinary action against the prescriber, pharmacist, hospital, or facility, except in cases of recklessness or gross negligence.

       (2) A health-related licensing board, the Department of Public Health, the State Board of Pharmacy, or any other state board or agency responsible for the licensure or regulation of health care professionals shall not pursue an administrative or disciplinary action against a prescriber, pharmacist, or other licensed health care professional or hospital or inpatient facility for publicly or privately expressing a medical opinion that does not align with the opinions of the health care professional's or licensee's respective board, agency, or department.

    (E) A political subdivision, public official, or state agency shall not enforce any rule or order issued by a federal agency that prohibits issuing a prescription for or dispensing an off-label drug.

    (F) At no time shall a patient in a hospital or inpatient facility be denied sufficient means of fluids or nutrition, unless that wish is clearly stated in the patient's end-of-life health directive, as that directive is defined by the patient or patient's health care power of attorney, or the denial is necessary for a medical procedure, including a diagnostic or surgical procedure, and then only for the shortest amount of time medically possible and with the informed consent of the patient or person holding the patient's health care power of attorney.

SECTION 3.  This act takes effect July 1, 2024.

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